Association Between Dermatoporosis and Fractural Risk

Dermatoporosis Clinical Trial

— DermatOstéo  

Official title:

Association Between Dermatoporosis and Fractural Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998228
• Other study ID #: TSE_2019_11
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: November 2020
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is a need for new tools to identify patients who may have osteoporosis before a fracture occurs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patient aged between 40 and 90 years old who has to undergo a bone densitometry (BMD) examination by dual X-ray absorptiometry

• Affiliate or beneficiary of a Social Security scheme

• Express consent to participate in the study.

Exclusion Criteria:

• Patient benefiting from a legal protection measure

• Pregnant or nursing woman.

Related Conditions & MeSH terms

• Dermatoporosis

Intervention

Diagnostic Test:
• Dual X-ray absorptiometry (DMO) densitometry.
Simple clinical examination with forearm inspection and palpation; Radiological examination of BMD; Calculation of the FRAX® score; Fact sheet on patients with dermatoporosis, proposal of a topical treatment (cosmetic cream) and completion of the questionnaire specific to dermatoporosis

Locations

Country	Name	City	State
France	Hôpital Fondation Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare fracture risk between patients with dermatoporosis and those without dermatoporosis	The fracture risk will be calculated using the FRAX score. The presence of dermatoporosis will be assessed by a simple clinical examination of the forearms and defined by the presence of three clinical signs: cutaneous atrophy, Bateman purpura and presence of pseudo-stellar scars.	BASELINE